(Senior-) Scientist

BÜHLMANN Laboratories AG; Schönenbuch; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

BÜHLMANN Laboratories AG, based near Basel, Switzerland, seeks a Senior-/Scientist to lead gastroenterology IVD development projects. You will manage phases, evaluate data, plan bench work, and ensure regulatory compliance, while collaborating with external partners and mentoring junior staff.

The role emphasizes scientific leadership, immunodiagnostic expertise, and hands-on lab work within a GMP environment, contributing to international patient care.

Qualifikationen

• Education: Bachelor, Master, or PhD in Biology, Chemistry, Biochemistry, Immunology, or related field.
• Proven experience in IVD product development and design transfer processes.
• Strong biostatistical skills and data evaluation experience.
• Excellent English, good German is a plus.

Aufgaben

• Lead development projects across feasibility, optimization, transfer, and validation phases.
• Supervise workstreams and act as deputy to the Lead Manager.
• Plan and execute laboratory experiments for IVD kit development and validation.
• Execute immunological assays (ELISA, PETIA, Flow Cytometry) and handle samples.
• Create and review DHF/DMR, SOPs, and risk management files.
• Perform advanced data evaluation and present results to teams and stakeholders.
• Foster external collaborations for product evaluations.
• Maintain GMP-compliant lab operations and mentor staff.

Kenntnisse

Project management

Data analysis

Biostatistics

Team collaboration

Leadership

Ausbildung

Bachelor/Master/PhD in Biology/ Chemistry/ Immunology

Tools

Origin

R

Jobbeschreibung

Shape the future of diagnostics – join our Development team!

BÜHLMANN Laboratories AG is an internationally active and growing life sciences company headquartered in Schönenbuch, near Basel, Switzerland. With 50 years of excellence in in-vitro diagnostics (IVD), we develop, manufacture, and distribute innovative diagnostic solutions trusted by hospitals and laboratories around the world.

To strengthen our Gastroenterology IVD Development team, we are looking for a dedicated and analytical professional as:

(Senior-) Scientist (m/w/d) 100%

In this key role, you will act as a project manager, project phase lead, and workstream leader within gastroenterology IVD product development. You are responsible for the independent, scientifically sound evaluation, laboratory execution, data analysis, and regulatory-compliant work for developing new IVD assays, optimizing existing products, validating kits, and transferring designs to Operations. Additionally, you will support unit leadership and act as a deputy for the Lead Manager where applicable.

Your Role – Strategic. Global. Impactful.

• Project Management & Phase Leadership: Lead development projects across feasibility, optimization, transfer, and validation phases; manage project plans, budgets, risk mitigation, and cross-departmental alignment.

• Workstream Management & Deputy Function: Supervise workstream contributors, coordinate multi-functional actions, and serve as deputy to the Lead Manager Gastroenterology IVD Development / Director.

• Experimental Planning & Bench Work: Plan, execute, and evaluate complex laboratory experiments for IVD kit development, assay optimization, and performance/stability assessments.

• Immunological Testing & Assays: Execute assays across multiple platforms (e.g., ELISA, PETIA, Flow Cytometry) and handle biological sample preparation (stool, blood, urine).

• Quality & Regulatory Documentation: Create and review critical technical documentation, including Design History Files (DHF), Device Master Records (DMR), SOPs, and risk management files.

• Data Evaluation & Biostatistics: Perform advanced data evaluation, apply biostatistical models, and present analytical findings to internal teams and external stakeholders.

• External Collaborations: Initiate and maintain scientific collaborations with external partners and clinical experts for product evaluations.

• Lab Management & Mentorship: Maintain instrument compliance within a GMP environment, train laboratory staff, and supervise students/interns.

Your Profile – Visionary. Collaborative. Data-driven.

• Education: Bachelor, Master of Science, or PhD degree in Biology, Chemistry, Biochemistry, Immunology, or a related field.
• Professional Experience: Proven experience in IVD product development, product validation, and design transfer processes.
• Technical & Scientific Background: Strong theoretical and practical foundation in immunodiagnostic techniques and diverse analytical platforms.
• Data & Biostatistics: Profound biostatistical skills and advanced experience with data evaluation software (e.g., Origin, R).
• Quality & Compliance: In-depth knowledge of IVD regulatory requirements, DHF/DMR creation, risk management, and GMP lab standards.
• Leadership & Soft Skills: Strong self-management, high precision, excellent collaboration and motivation skills, resilience, and assertive communication.
• Languages: Highly proficient in spoken and written English; conversational/basic German is a strong asset.

What We Offer

• A senior-level position with high visibility, project ownership, and leadership responsibility in IVD innovation.
• Close collaboration with an interdisciplinary team of experts and direct impact on international patient care.
• Dynamic, stable medium-sized business environment with modern laboratory infrastructure.

Are you ready to advance your career in gastroenterology IVD development?